Real-world use, perception, satisfaction, and adherence of calcipotriol and betamethasone dipropionate PAD-cream in patients with plaque psoriasis in Spain and Germany: results from a cross-sectional, online survey.

BACKGROUND: Psoriasis significantly impacts patients' quality of life (QoL). Dissatisfaction and non-adherence are major barriers associated with topical treatments. A cream based on the polyaphron dispersion (PAD) Technology containing a fixed-dose of calcipotriol (CAL) and betamethasone dipropionate (BDP) was designed for a patient-friendly psoriasis management. The CAL/BDP PAD-cream demonstrated efficacy, convenience, and safety/tolerability in clinical trials. OBJECTIVES: This research assesses the real-world use, perception, satisfaction, and adherence of CAL/BDP PAD-cream among plaque psoriasis patients. METHODS: Between September-November 2023, psoriasis patients from Spain and Germany using or having used CAL/BDP PAD-cream for >2 weeks were recruited via Wefight network to complete a 30-questions online survey. Anonymized results were pooled for descriptive statistical analysis. RESULTS: The survey was completed by 129 patients (mean age: 43 years; 66% females; mean psoriasis duration: 12 years). Most patients (93%) were satisfied with CAL/BDP PAD-cream. The 66% reported high adherence (visual analogue scale 80-100) and 91% preferred CAL/BDP PAD-cream to their previous topical(s). Patients highlighted its ease/convenience of application, tolerability, and lack of itching/burning. CONCLUSIONS: Psoriasis patients treated with CAL/BDP PAD-cream in a real-world setting show high satisfaction, good adherence, and a positive perception of the product, suggesting that favorable outcomes observed in clinical trials translate to real clinical practice.

Burden of Topical Treatments in Psoriasis and Preferred Criteria of Choice: A Survey-Based Evaluation of Patients in Europe.

INTRODUCTION: Topical treatments (TT) are widely used in psoriasis management. While psoriasis itself has been associated with diminished quality of life and mental well-being, the impact of TT remains underexplored. This study aimed to evaluate the burden of TT on the daily lives of patients with psoriasis, the convenience of the TT, and the choice criteria. METHODS: Patients were recruited across five countries (France, Germany, Italy, Spain, UK) by Wefight and the International Federation of Psoriasis Associations (IFPA) to complete a 29-item online survey. RESULTS: A total of 766 patients completed the survey (54% female, mean age of 53 years). The mean body surface area covered by psoriasis was 7%, predominantly on the scalp and elbows. Participants had been living with psoriasis for a mean duration of 18 years. Of the respondents, 34% reported feeling affected by their TT in their daily routines and activities. Those feeling affected were more likely to have a more complex disease, be using more treatments, or be diagnosed more recently compared to those less affected. Among those most affected by their TT, 27% reported a strong impact on mental health, 30% on sexual life, and 25% on physical activities, compared to 7%, 6% and 4% in those least affected, respectively. Both cohorts considered tolerability factors such as "does not cause itching/burning" and "good tolerability" as most important when choosing a topical. However, only least affected participants regarded convenience factors such as "does not run off," "ease of application," "does not leave stains" among others equally as important. CONCLUSION: Overall, one-third of patients report a significant burden of TT on their daily lives. These patients have different criteria of choice, highlighting the importance of communication between physicians and patients to tailor treatment to individual preferences, thereby enhancing adherence and treatment outcomes.

Calcipotriol and Betamethasone Dipropionate Cream Based on PAD Technology for the Treatment of Plaque Psoriasis: A Narrative Review.

Topical treatment plays a crucial role in psoriasis management, with non-adherence being a major barrier to treatment success. The fixed-dose combination of calcipotriol (CAL) and betamethasone dipropionate (BDP) represents the first-line choice in topical psoriasis treatment. A CAL/BDP cream based on polyaphron dispersion (PAD) Technology has emerged as a novel formulation for a more convenient topical treatment of psoriasis. This article aims to summarize the most relevant published evidence about CAL/BDP PAD-cream and its underlying PAD Technology. The PAD Technology enables CAL and BDP stability in an aqueous cream through a multimolecular shell structure, as well as it increases the penetration of both active ingredients into the epidermis and dermis. This technology also demonstrated to increase the cosmetic acceptability and to provide the desirable sensory properties for a topical psoriasis treatment. Two phase III clinical trials have been conducted so far with CAL/BDP PAD-cream. Findings from both trials revealed high efficacy with a fast onset of action, a favourable safety and tolerability profile and convenience for CAL/BDP PAD-cream compared to CAL/BDP gel. In the trial including patients with psoriasis affecting the scalp (MC2-01-C7), results support the use of CAL/BDP PAD-cream in scalp psoriasis. An anchored matching-adjusted indirect comparison (MAIC) was conducted to compare CAL/BDP PAD-cream and CAL/BDP foam, as both products had been previously compared to CAL/BDP gel. CAL/BDP PAD-cream and CAL/BDP foam showed equivalent efficacy and quality of life at their recommended treatment duration, whereas greater treatment satisfaction for CAL/BDP PAD-cream was found after one week of treatment. Overall, the high patient acceptability and treatment satisfaction observed with CAL/BDP PAD-cream in clinical trials may lead to improved adherence and hence higher efficacy in clinical practice.

Sensory properties analysis of a calcipotriol and betamethasone dipropionate cream vehicle formulated with an innovative PAD Technology for the treatment of plaque psoriasis on the skin and scalp.

Background: In psoriasis, poor treatment adherence is frequently related to low efficacy and limited cosmetic acceptability from the patients' perspective. This study aimed to characterize the sensorial attributes of a calcipotriol (CAL) and betamethasone dipropionate (BDP)-cream vehicle based on polyaphron dispersion (PAD) Technology and to compare them with the conventional ointment and oleogel formulations for psoriasis. Methods: A panel of 16 experts assessed sensory properties at four different stages: appearance, pick up, rub out and afterfeel. Descriptive sensory analysis was used to evaluate relevant attributes. Each attribute was rated on a line scale (range 0-100%). Active ingredients were not used because panellists were healthy volunteers, and vehicle formulations needed to be used instead. Results: CAL/BDP PAD-cream vehicle was evaluated as having a low stickiness, low grease behaviour, good wetness, and good spreadability. Ointment showed the least desirable behaviour regarding these properties. Moreover, once CAL/BDP PAD-cream vehicle was absorbed, the gloss disappeared quickly, leaving low stickiness and a low amount of residue. This afterfeel behaviour was not observed with ointment. The oleogel formulation had good sensory properties, similar to CAL/BDP PAD-cream vehicle, but with lower integrity of shape, lower wetness and higher greasiness. Conclusion: Overall, CAL/BDP PAD-cream vehicle has the desirable requirements for a topical product for the treatment of psoriasis, with better sensory properties than ointment and easier manipulation than oleogel, which may lead to greater acceptance and adherence.

A novel, fixed-dose calcipotriol and betamethasone dipropionate cream for the topical treatment of plaque psoriasis: Direct and indirect evidence from phase 3 trials discussed at the 30th EADV Congress 2021.

Four posters about the novel, fixed-dose calcipotriol and betamethasone dipropionate cream (CAL/BDP cream) based on Poly-Aphron Dispersion (PAD) Technology were presented at the 30th European Academy of Dermatology and Venereology (EADV) Congress 2021 and are summarized here. CAL/BDP cream was compared in two randomized, phase 3 trials to vehicle and active comparator (CAL/BDP gel/topical suspension [TS]) in adults with plaque psoriasis (NCT03802344 and NCT03308799). Pooled data from both trials demonstrated significant greater efficacy in favour of CAL/BDP cream for all efficacy endpoints, including PGA treatment success, mPASI, and mPASI75 compared to CAL/BDP gel/TS. CAL/BDP cream was well tolerated and comparable to CAL/BDP gel/TS with no adverse drug reactions with a frequency >1%. In the NCT03308799 study, CAL/BDP cream demonstrated a substantial improvement in the proportion of participants achieving a minimum 4-point improvement on the peak pruritus numeric rating scale (NRS) score compared with vehicle at Weeks 1, 4 and 8. CAL/BDP cream also improved quality of life (QoL), as assessed through the Dermatology Life Quality Index (DLQI), and the EQ-VAS at Week 8 compared with active comparator. Treatment convenience of CAL/BDP cream, as measured by the Psoriasis Treatment Convenience Scale, was superior to CAL/BDP gel/TS at all studied timepoints, including questions addressing formulation's greasiness and overall treatment satisfaction. Finally, an indirect comparison following the Bucher's method of adjusted indirect comparison and the difference-in-differences method was conducted to compare CAL/BDP cream and CAL/BDP foam, as both therapies have been compared to CAL/BDP gel/TS. Indirect evidence showed that treatment with CAL/BDP cream was associated with a trend for greater QoL improvement than CAL/BDP foam when DLQI improvement was assessed at the recommended treatment duration of 8 weeks for CAL/BDP cream and 4 weeks for CAL/BDP foam. CAL/BDP cream was statistically superior versus CAL/BDP foam in four out of five treatment satisfaction domains.

An anchored matching-adjusted indirect comparison of fixed-dose combination calcipotriol and betamethasone dipropionate (Cal/BDP) cream versus Cal/BDP foam for the treatment of psoriasis.

OBJECTIVES: To undertake a comparison of Cal/BDP cream versus foam for the treatment of plaque psoriasis, with cross-trial population differences accounted for. MATERIALS AND METHODS: An anchored matching-adjusted indirect comparison was undertaken, using individual patient data for Cal/BDP cream and published aggregated data for Cal/BDP foam. Altogether, 11 outcomes were analyzed, including PGA success, mPASI75, DLQI-related outcomes and treatment satisfaction across numerous domains. For each outcome an odds ratio or mean difference was calculated to represent the relative efficacy of Cal/BDP cream versus foam. Methods were guided by NICE Decision Support Unit recommendations. RESULTS: After adjustment, baseline characteristics were balanced across treatment arms in each analysis. There were no statistically significant differences in PGA success, mPASI75 or DLQI outcomes between Cal/BDP cream and foam when they were compared after their recommended treatment durations (8 weeks for cream and 4 weeks for foam). For treatment satisfaction after 1 week of treatment, Cal/BDP cream was significantly superior to the Cal/BDP foam in all but one domain of the questionnaire. CONCLUSIONS: Cal/BDP cream and Cal/BDP foam have equivalent efficacy and HRQoL (measured in DLQI) outcomes when used for the topical treatment of plaque psoriasis at their recommended treatment durations. A comparison of treatment satisfaction assessments after 1 week of treatment demonstrated that patients find Cal/BDP cream to be more convenient than foam.

Ciclopirox Hydroxypropyl Chitosan (CPX-HPCH) Nail Lacquer and Breathable Cosmetic Nail Polish: In Vitro Evaluation of Drug Transungual Permeation Following the Combined Application.

BACKGROUND: Onychomycosis produces nail chromatic alterations that lead patients to mask them with cosmetic enamels. Objectives: Evaluate drug transungual permeation and antimycotic activity against selected strains after application of CPX-HPCH nail lacquer (NL) on the nail pre-covered with breathable cosmetic polish. METHODS: CPX transungual permeation after applying CPX-HPCH NL once or twice a day on bovine hoof membranes pre-covered with a breathable cosmetic nail polish was compared to that obtained applying CPX-HPCH NL directly on the membrane. The relevant experimental permeates underwent an in vitro susceptibility test. RESULTS: After CPX-HPCH NL application once a day, the drug transungual flux in the presence of cosmetic product tended to decrease while maintaining the antifungal activity. Two daily applications of CPX-HPCH NL on the membrane pre-covered with cosmetic polish exhibited the same permeation profile as daily application of the medicated lacquer directly on the nail as well as the same microbiological activity. CONCLUSIONS: The breathable cosmetic nail polish can be applied on the nail affected by onychomycosis in association with CPX-HPCH NL to mask the imperfections. The application of CPX-HPCH NL twice a day appears to be a good solution to obtain the same results as for a daily application without the presence of the cosmetic layer.

Efficacy, quality of life, and treatment satisfaction: an indirect comparison of calcipotriol/betamethasone dipropionate cream versus foam for treatment of psoriasis.

OBJECTIVE: To assess how the use of calcipotriol and betamethasone dipropionate (Cal/BDP) cream impacted efficacy, patients' quality of life (QoL), and treatment satisfaction versus Cal/BDP foam. METHODS: Data from clinical trials of Cal/BDP cream and foam were analyzed, by applying the common anchor Cal/BDP gel. Efficacy was assessed by Physician Global Assessment (PGA) treatment success and ≥75% reduction in Psoriasis Area and Severity Index (PASI75 response); QoL by Dermatology Life Quality Index (DLQI); treatment satisfaction by Psoriasis Treatment Convenience Scale (PTCS) and Topical Product Usability Questionnaire (TPUQ). RESULTS: Treatment with Cal/BDP cream was on par with foam on PGA treatment success (risk ratio (RR) for Cal/BDP cream versus foam: 0.80; 95%CI: 0.56, 1.14; p = .21) and PASI75 response (RR for Cal/BDP cream vs. foam: 0.85; 95%CI: 0.64, 1.13; p = .27) when assessed at the treatment duration of 8 weeks for Cal/BDP cream and 4 weeks for Cal/BDP foam. Treatment with Cal/BDP cream was associated with significantly greater treatment satisfaction versus foam on the domains: overall treatment satisfaction (p = .01), "ease of application" (p < .001), "lack of greasiness" (p < .001), "moisturizing effect" (p = .01), and almost significantly greater improvement on the domain "easily incorporated into daily routine" (p = .07). Furthermore, there was a trend for greater DLQI improvement with cream versus foam when assessed at recommended treatment duration [mean difference (MD) for Cal/BDP cream vs. foam: -1.00; 95%CI: -2.20, 0.20; p = .10]. CONCLUSIONS: Indirect comparison analyses showed that Cal/BDP cream significantly improves treatment satisfaction and tends to improve QoL versus foam. Cal/BDP cream is on par with foam on efficacy.

A multicentre, randomised, parallel-group, double-blind, vehicle-controlled and open-label, active-controlled study (versus amorolfine 5%), to evaluate the efficacy and safety of terbinafine 10% nail lacquer in the treatment of onychomycosis.

BACKGROUND: Onychomycosis is a difficult-to-treat fungal nail infection whose treatment can involve systemic or topical antifungal approaches. OBJECTIVES: To assess the efficacy and safety of terbinafine 10% nail lacquer in distal-lateral subungual onychomycosis (DLSO). PATIENTS/METHODS: Patients with mild-to-moderate DLSO were randomised (3:3:1) to receive double-blind topical terbinafine 10% (n = 406) or its vehicle (n = 410) administered once daily for 4 weeks and then once weekly for 44 weeks, or open-label topical amorolfine 5% (n = 137) for 48 weeks, with a 12-week follow-up period. The primary efficacy endpoint, complete cure rate at Week 60, was a composite of negative potassium hydroxide (KOH) microscopy, negative culture for dermatophytes and no residual clinical involvement of the target big toenail. RESULTS: Complete cure rates at Week 60 in the terbinafine, vehicle and amorolfine groups were 5.67%, 2.20% and 2.92%, respectively (odds ratio (OR) vs vehicle = 2.68; 95% confidence intervals (CI): 1.22-5.86; p = .0138). Statistically significant differences in responder (negative KOH and negative culture and ≤10% residual clinical involvement) and mycological cure rates (negative KOH and negative culture) at Week 60 were obtained between terbinafine and vehicle. Terbinafine was well-tolerated with no systemic adverse reactions identified; the most common topical adverse reactions were erythema and skin irritation. CONCLUSIONS: Terbinafine 10% nail lacquer was an effective treatment for mild-to-moderate onychomycosis improving both clinical and mycological criteria compared with vehicle. Furthermore, there may be some benefits compared to the currently available topical agent, amorolfine 5%. Treatment was well-tolerated and safe.

Clinical and Economic Evaluation of Transdermal Oxybutynin in the Treatment of Overactive Bladder in Spain.

Background: This study evaluated the clinical outcomes and economic results of transdermal oxybutynin compared to fesoterodine, tolterodine, solifenacin, oxybutynin, trospium chloride, and mirabegron for overactive bladder syndrome in Spain. Materials and Methods: A Markov model was built with monthly cycles for a 5-year time frame. The model reflected clinical events, discontinuation, dose scaling and change in treatment according to actual clinical practice. Based on experts' opinion and the literature, the use of resources and Spanish costs were incorporated into the model. The measure of efficiency used was the cost per quality-adjusted life year (QALY) gained. The economic evaluation was performed from the perspective of the Spanish healthcare system, discounting costs (€2017) and effects at 3%. The robustness of the results was validated with a deterministic and probabilistic sensitivity analysis. Results: After a year, transdermal oxybutynin was seen to have greater persistence deriving from its better risk/benefit balance compared to muscarinic antagonists and mirabegron (55% transdermal oxybutynin, 33% mirabegron, 25% tolterodine, 27% fesoterodine, 25% solifenacin, 23% trospium chloride and 17% oxybutynin). At 5-years, better persistence resulted in improvements in QALY gained by transdermal oxybutynin of 0.050, 0.040, 0.039, 0.038, 0.034 and 0.010 compared to oxybutynin, fesoterodine, solifenacin, trospium chloride, tolterodine and mirabegron, respectively. The incremental cost-effectiveness ratio of transdermal oxybutynin ranged from €1313.96 per QALY gained compared to fesoterodine to €14 101.57 per QALY gained compared to trospium chloride. Conclusions: Kentera® (transdermal oxybutynin) is a cost-effective treatment in overactive bladder syndrome compared to muscarinic antagonists and mirabegron.

[Descriptive study of the use of DMARD in patients with rheumatoid arthritis or persistent arthritis who start drug treatment in Spain (FIRST)]. / Estudio descriptivo de la utilización de los FAMES en los pacientes con artritis reumatoide o artritis persistente que inician tratamiento farmacológico en España. (ESTUDIO FIRST).

INTRODUCTION: Rheumatoid arthritis is clinically very heterogeneous and variable in its progression, and no one treatment works the same for all patients, as this will depend on the clinical course and specific situations. OBJECTIVE: To describe the treatment with DMARDs established for the first time in patients with rheumatoid arthritis (RA) or persistent arthritis (PA) in routine clinical practice in Spain. MATERIAL AND METHODS: Epidemiological, cross-sectional, uncontrolled, multicenter study in 15 regions of Spain during a period of five months (July to November 2006). We included patients of both genders, aged 18 years and diagnosed with RA according to ACR criteria or PA defined as any arthritis (oligoarthritis or polyarthritis) lasting ≥12 weeks, which would be given DMARD to treat their disease. RESULTS: 1079 patients were recruited, 915 analyzed (33% ♂/♀ 67%) meeting all the criteria required to be evaluated in the study. Mean age of patients was 54.6 (SD=15.4) years. The mean time from onset of symptoms until the 1st visit with the rheumatologist was 6.3 (11.3) months and the time from the 1st visit with the rheumatologist and the start of treatment was 4 (13.5) months. Of the patients tested, 96.7% was treated with at least one DMARD, 62.1% were given NSAIDs, corticosteroids to 59.2% and 3.8% biological therapy. In patients who received DMARDs, 90.3% received treatment with a single DMARD, 9.5% with 2 DMARDs and 0.2% with three DMARDs. In polytherapy, the DMARDs that are most often administered together were MTX + hydroxychloroquine (4.8%), MTX + leflunomide (2.0%) and MTX + sulfasalazine (1.5%). The most frequently used DMARD in monotherapy was MTX (81.3%), followed by leflunomide (4.1%) and hydroxychloroquine (3.2%). In 89.6%, the treatment of first choice was adequate according to the SER. CONCLUSION: The most common pattern of initial treatment of RA is MTX monotherapy. Treatment of RA by rheumatologists has been homogenized in recent years.

Estudio descriptivo de la utilización de los FAMES en los pacientes con artritis reumatoide o artritis persistente que inician tratamiento farmacológico en España. (ESTUDIO FIRST) / Descriptive study of the use of DMARD in patients with Rheumatoid arthritis or persistent arthritis who start drug treatment in Spain (FIRST)

Introducción. La artritis reumatoide es clínicamente muy heterogénea y variable en su evolución, lo que ocasiona que no se pueda detallar un mismo tratamiento para todos los pacientes, ya que éste va a depender del curso clínico y de situaciones concretas que se van a presentar a lo largo del mismo. Objetivo. Realizar una descripción del tratamiento con fármacos modificadores de la enfermedad (FAME) que se instauran por primera vez en pacientes con artritis reumatoide (AR) o artritis persistente (AP) en la práctica clínica habitual en España. Material y métodos. Estudio epidemiológico, transversal, no controlado, multicéntrico realizado en 15 comunidades autónomas de España durante un período de 5 meses (julio a noviembre del 2006). Se incluyeron pacientes de ambos sexos, mayores de 18 años y diagnosticados de AR según los criterios de la ACR o bien de AP definida como toda artritis (oligoartritis o poliartritis) ≥12 semanas de duración, a los que se les iba a administrar el primer FAME para tratar su enfermedad. Resultados. Se reclutaron 1.079 pacientes, pero finalmente, 915 (33% ♂/67% ♀) cumplieron todos los criterios exigidos para ser evaluados en el estudio. La edad media de los pacientes fue de 54,6 (DE=15,4) años. El tiempo medio desde la aparición de los síntomas hasta la 1.a visita con el reumatólogo fue de 6,3 (11,3) meses y el tiempo desde la 1.a visita con el reumatólogo y el inicio del tratamiento fue de 4 (13,5) meses. Del total de pacientes evaluados, al 96,7% se les instauró tratamiento con al menos un FAME, al 62,1% se les administraron AINE, al 59,2% corticoesteroides y al 3,8% una terapia biológica. En los pacientes que recibieron FAME, el 90,3% recibió tratamiento con un solo FAME, el 9,5% con 2 FAME y el 0,2% con 3 FAME. En politerapia, los FAME que más a menudo se administraron conjuntamente fueron MTX+Hidroxicloroquina (4,8%), MTX+Leflunomida (2,0%) y MTX+Sulfasalazina (1,5%). El FAME más frecuentemente utilizado en monoterapia fue el MTX (81,3%), seguido de la leflunomida (4,1%) y la hidroxicloroquina (3,2%) En el 89,6%, el tratamiento de primera elección fue el adecuado según las recomendaciones de la SER. Conclusión. La pauta de tratamiento de inicio de la AR más frecuente es el MTX en monoterapia. El tratamiento de la AR por los reumatólogos se ha homogeneizado en los últimos años(AU)

Introduction. Rheumatoid arthritis is clinically very heterogeneous and variable in its progression, and no one treatment works the same for all patients, as this will depend on the clinical course and specific situations. Objective. To describe the treatment with DMARDs established for the first time in patients with rheumatoid arthritis (RA) or persistent arthritis (PA) in routine clinical practice in Spain. Material and methods. Epidemiological, cross-sectional, uncontrolled, multicenter study in 15 regions of Spain during a period of five months (July to November 2006). We included patients of both genders, aged 18 years and diagnosed with RA according to ACR criteria or PA defined as any arthritis (oligoarthritis or polyarthritis) lasting ≥12 weeks, which would be given DMARD to treat their disease. Results. 1079 patients were recruited, 915 analyzed (33% ♂/♀ 67%) meeting all the criteria required to be evaluated in the study. Mean age of patients was 54.6 (SD=15.4) years. The mean time from onset of symptoms until the 1st visit with the rheumatologist was 6.3 (11.3) months and the time from the 1st visit with the rheumatologist and the start of treatment was 4 (13.5) months. Of the patients tested, 96.7% was treated with at least one DMARD, 62.1% were given NSAIDs, corticosteroids to 59.2% and 3.8% biological therapy. In patients who received DMARDs, 90.3% received treatment with a single DMARD, 9.5% with 2 DMARDs and 0.2% with three DMARDs. In polytherapy, the DMARDs that are most often administered together were MTX + hydroxychloroquine (4.8%), MTX + leflunomide (2.0%) and MTX + sulfasalazine (1.5%). The most frequently used DMARD in monotherapy was MTX (81.3%), followed by leflunomide (4.1%) and hydroxychloroquine (3.2%). In 89.6%, the treatment of first choice was adequate according to the SER. Conclusion. The most common pattern of initial treatment of RA is MTX monotherapy. Treatment of RA by rheumatologists has been homogenized in recent years(AU)

Análisis farmacoeconómico de Metoject® en el tratamiento de la artritis reumatoide en España / Pharmacoeconomic analysis of Metoject® in the treatment of rheumatoid arthritis in Spain

Objetivos. El objetivo de este estudio ha sido comparar la eficiencia de utilizar el metotrexato subcutáneo (Metoject®) con respecto al metotrexato oral en el manejo de pacientes con AR en España. Métodos. Se ha realizado un análisis coste-efectividad/utilidad del tratamiento de la AR temprana utilizando un modelo de Markov. El modelo ha permitido estimar la efectividad a largo plazo del tratamiento de la AR en función de los datos de la literatura y de la opinión de expertos y combinarlo con información de los costes en España. El análisis se ha realizado desde la perspectiva del Sistema Nacional de Salud, utilizando un horizonte temporal de 5 años y de toda la vida del paciente. Todos los costes se expresaron en euros del año 2009 y se ha utilizado una tasa de descuento del 3%. Resultados. La razón de coste (solo costes farmacológicos) por año de vida ajustado por calidad (AVAC) ganado con Metoject® fue de 25.173–35.807€ a los 5 años y de 19.056–25.351€ para toda la vida. Al tener en cuenta los costes directos de la AR se observó que el coste-efectividad a los 5 años fue de 29.682–42.175€/AVAC ganado y para toda la vida fue de 22.514–29.848€/AVAC ganado. Conclusiones. Los costes adicionales de Metoject® respecto a metotrexato oral se verían compensados por su mejora en efectividad, expresada en términos de AVAC, revelando que Metoject® podría ser un tratamiento costeefectivo para la AR en el Sistema Nacional de Salud según el umbral asumido en España (AU)

Objectives. The aim of this study was to compare the clinical and economic consequences of using subcutaneous methotrexate (Metoject®) with respect to oral methotrexate in the management of rheumatoid arthritis (RA) in Spain. Methods. A cost-effectiveness analysis was performed to compare early treatment of RA using a Markov model. The model allowed us to estimate long term efficacy of RA treatment based on data from the literature and expert opinion, and to combine this data with costs of managing RA in Spain. The perspective of the study was from the National Health System point of view, using a time horizon of 5 years and patient lifetime. All costs were expressed in 2009 euros and a 3% discount rate was applied. Results. The cost (only pharmacologic costs) per quality-adjusted life year (QALY) gained with Metoject® went from 25,173 to 35,807€ at 5 years and from 19,056 to 25,351€ for patient lifetime. When direct costs in RA treatment were considered, it was observed that cost-effectiveness at 5 years went from 29,682 to 42,175€/QALY gained, and for patient lifetime from 22,514 to 29,848€/ QALY gained. Conclusions. Additional costs of Metoject® with respect to oral methotrexate would be offset by their improved effectiveness, expressed in QALY, showing that Metoject® could be a cost-effective treatment option for RA in the Spanish Health System assuming a spanish threshold (AU)

[Pharmacoeconomic analysis of Metoject(®) in the treatment of rheumatoid arthritis in Spain]. / Análisis farmacoeconómico de Metoject(®) en el tratamiento de la artritis reumatoide en España.

OBJECTIVES: The aim of this study was to compare the clinical and economic consequences of using subcutaneous methotrexate (Metoject(®)) with respect to oral methotrexate in the management of rheumatoid arthritis (RA) in Spain. METHODS: A cost-effectiveness analysis was performed to compare early treatment of RA using a Markov model. The model allowed us to estimate long term efficacy of RA treatment based on data from the literature and expert opinion, and to combine this data with costs of managing RA in Spain. The perspective of the study was from the National Health System point of view, using a time horizon of 5 years and patient lifetime. All costs were expressed in 2009 euros and a 3% discount rate was applied. RESULTS: The cost (only pharmacologic costs) per quality-adjusted life year (QALY) gained with Metoject(®) went from 25,173 to 35,807€ at 5 years and from 19,056 to 25,351€ for patient lifetime. When direct costs in RA treatment were considered, it was observed that cost-effectiveness at 5 years went from 29,682 to 42,175€/QALY gained, and for patient lifetime from 22,514 to 29,848€/ QALY gained. CONCLUSIONS: Additional costs of Metoject(®) with respect to oral methotrexate would be offset by their improved effectiveness, expressed in QALY, showing that Metoject(®) could be a cost-effective treatment option for RA in the Spanish Health System assuming a spanish threshold.

Estudio coste-efectividad de leflunomida frente a metotrexato / No disponible

No disponible

Acceptability of lansoprazole orally disintegrating tablets in patients with gastro-oesophageal reflux disease : ACEPTO study.

OBJECTIVE: To assess the acceptability of lansoprazole orally disintegrating tablets (LODT) in patients with gastro-oesophageal reflux disease (GORD). METHODS: A multicentre, observational, cross-sectional study of patients diagnosed with GORD aged > or =18 years under the care of 272 gastroenterologists. Acceptability was determined by global patient assessment whereby the drug's organoleptic characteristics and properties were evaluated by a self-administered 11-item ad hoc questionnaire with a 5-point Likert-type scale. RESULTS: A total of 734 patients (mean age 49.6 years [SD = 15.2]) with GORD who had been prescribed LODT > or =14 days prior to inclusion in the study were evaluable for the main endpoint. Of these, 51.1% were men. Most patients (80.7%) had been treated with doses of LODT 30mg/day for an average of 52.7 days (SD = 59.3). Overall, 93.6% of patients rated LODT treatment as 'very acceptable' or ''acceptable'. The degree of acceptability was associated with the perception that the formulation helps treatment compliance (p < 0.001). The drug's properties were rated as follows: size 'neither large nor small' (70.0%); flavour 'very pleasant' or 'pleasant' (75.2%); intensity of flavour 'neither strong nor mild', 'mild' or 'very mild' (86.1%); no 'sandy sensation' (53.4%); speed of dissolving 'fast' or 'very fast' (80.2%); use of tablets 'very easy' or 'easy' (92.4%) and use of tablets 'very convenient' or 'convenient' (91.0%). Three adverse reactions, none of them serious, were reported in three patients (0.4%). CONCLUSIONS: LODT were well accepted by patients with GORD. Patients reported that this formulation improved compliance with therapy. Tolerability was excellent.

The burden of migraine in Spain: beyond direct costs.

OBJECTIVE: To estimate the economic burden of migraine in Spain, from the societal perspective. METHODS: The Spanish 2001 annual direct (pharmacy, primary care, specialist and emergency room visits) and indirect (missed workdays and reduced work performance) costs were calculated using the prevalence approach. The human-capital method was used to calculate indirect costs. The sources used were published epidemiological and resource use studies using the International Headache Society diagnostic criteria from official and unofficial databases. RESULTS: The Spanish population with migraine was estimated to be 3,617,600 patients, 92.5% being of a working age. The economic burden of migraine was about euro 1076 million. The direct costs represented only 32.0% of the total burden (euro 344 million), 39.2% being for primary care visits, 28.7% for specialist visits, 20.5% for emergency room visits and a further 11.7% for migraine-specific prescription drugs (serotonin 5-HT(1B/1D) receptor agonists [triptans] 10.8%, ergots 0.9%). The indirect cost was estimated at euro 732 million annually, representing euro 453.55 per working patient with migraine. CONCLUSIONS: As in many other developed countries, migraine represents a considerable economic burden in Spain, especially in terms of productivity losses. Therefore, activities should be specifically directed at reducing the indirect costs, and effective treatments, which significantly reduce productivity losses, should be publicly promoted.